A Study on the Effect of Food Containing Plant Extract on the Alleviation of the Symptom of a Hangover on the Next Day of Drinking
- Conditions
- o
- Registration Number
- JPRN-UMIN000040996
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Statistically significant difference was confirmed in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 42
Not provided
(1) Subjects with DD type in the alcohol patch test. (2) Subjects who have never had a hangover. (3) Subjects who have excessive alcohol intake more than 60 g/day of pure alcohol equivalent. (4) Subjects who contract disease and are under treatment. (5) Subjects who have a history of and/or contract serious diseases (eg, hyperlipidemia, high blood pressure, diabetes, psychiatric disease, sleeping disorder ). (6) Subjects who used a drug to treat a disease in the past 1 month (except temporal usage for headache and cold). (7) Subjects who have a history of and/or contract serious diseases (eg, liver disease, kidney disease, heart disease, lung disease, blood disease). (8) Subjects who have a history and/or contract digestive disease (except disease of an appendix). (9) Subjects whose BMI are under 18.5 or 30 or more. (10) Subjects with serious anemia. (11) Subjects who have allergic reaction to ingredients of test foods and other foods or drugs. (12) Subjects with possible changes of life style, such as a long-term travel and a late-night shift, during test periods. (13) Subjects who have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve liver function (curcumin, clam extract, liver extract, etc.) in the past 3 months and/or are planning to use those foods during test periods. (14) Subjects who have difficulty in taking meals (dinner and lunch on the inspection day). (15) Subjects who are participating and/or had participated in other clinical studies within the last three months prior to the current study. (16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Questionnaires on a hangover
- Secondary Outcome Measures
Name Time Method